Reported Jul 17, 2024 · Ongoing
Presource kits and trays, labeled as
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Presource kits and trays, labeled as
10 of 10 products
| Model / number | Product as published |
|---|---|
SAN29ANCC3 | Cardiovascular Procedure Kit |
SAN29ANCC4 | Cardiovascular Procedure Kit |
SAN29ANCCL | Cardiovascular Procedure Kit |
SAN29ANCCM | Cardiovascular Procedure Kit |
SAN33CDCAS | Cardiovascular Procedure Kit |
SAN33CDCAT | Cardiovascular Procedure Kit |
| — | Cardiovascular Procedure Kit, Catalog Number SANOCAENSA |
SCV29ANCCA | Cardiovascular Procedure Kit |
SAN73LHKCC | Left Heart Kit |
SAN73LHKC6 | Left Heart Kit |
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 5088843969286810888439692860SAN29ANCC3, UDI/DI (CS/EA) 50888439692868/10888439692860, Lot Numbers: 377162 2 5088843979192910888439791921SAN29ANCC4, UDI/DI (CS/EA) 50888439791929/10888439791921, Lot Numbers: 404590 3 5088748857207710887488572079SAN29ANCCL, UDI/DI (CS/EA) 50887488572077/10887488572079, Lot Numbers: 227924, 248336, 268411, 295823, 330354, 441771, 470382, 485647 4 5088843991693310888439916935SAN29ANCCM, UDI/DI (CS/EA) 50888439916933/10888439916935, Lot Numbers: 538664 5 5019559410088710195594100889SAN33CDCAS, UDI/DI (CS/EA) 50195594100887/10195594100889, Lot Numbers: 7500, 27481, 47777, 66619, 84103, 98759, 654804, 664274, 670490, 690813, 719128, 742731, 769997, 789979, 806872, 821751, 853574, 892089, 905085, 929736, 955110, 974399, 989732 6 5019710639440110197106394403SAN33CDCAT, UDI/DI (CS/EA) 50197106394401/10197106394403, Lot Numbers: 105901, 124750, 166138, 184313, 213752, 228035, 247566 7 5019559465086310195594650865SANOCAENSA, UDI/DI (CS/EA) 50195594650863/10195594650865, Lot Numbers: 60783, 75070, 104936, 117262, 149856, 164959, 192358, 195004, 265705, 842090, 846704, 868814 8 5088843997253310888439972535SCV29ANCCA, UDI/DI (CS/EA) 50888439972533/10888439972535, Lot Numbers: 35435, 51272, 106300, 186438, 257038, 583559, 619303, 639545, 668446, 721926, 744092, 783887, 806636, 868787, 896632, 933968, 969941, 985419 9 5019559405634410195594056346SAN73LHKCC, UDI/DI (CS/EA) 50195594056344/10195594056346, Lot Numbers: 25179, 29199, 52789, 124487, 137706, 203053, 756293, 826474 10 5019710637556110197106375563SAN73LHKC6, UDI/DI (CS/EA) 50197106375561/10197106375563, Lot Numbers: 89496 - Amount recalled
- 17445 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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